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A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05895409
Collaborator
(none)
610
Enrollment
59
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about risk of progressive pulmonary fibrosis (PPF). The main questions it aims to answer are:

  • Risk factors of PPF

  • Prevalence of PPF

  • Mortality of PPF

Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis will enroll in this study.

  • All participants will have baseline investigations at the first visit having provided informed consent.

  • At the first visit, baseline characteristics will be collected including demographics, medical history, smoking history, complications and medication use. 50 mL of blood will be obtained. High resolution computed tomography (HRCT), full lung function tests and a 6 min walk test will be performed.

  • Further visits at 6 months and 12 months will include further 50 mL blood sampling. HRCT, full lung function tests and a 6 min walk test will be repeated.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    610 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multicenter Prospective Study of Risk Factors in Progressive Pulmonary Fibrosis
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jun 1, 2026
    Anticipated Study Completion Date :
    Jun 1, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    PF

    Patients with interstitial lung disease (ILD) of known or unknown etiology other than IPF who has radiological evidence of pulmonary fibrosis(PF).

    Outcome Measures

    Primary Outcome Measures

    1. Establish the correlation between Age (years) and progression to PPF [Up to 12 months]

    2. Establish the correlation between Gender (the proportion of female and the proportion of male) and progression to PPF [Up to 12 months]

    3. Establish the correlation between Body mass index (BMI, kg/m2) and progression to PPF [Up to 12 months]

    4. Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and progression to PPF [Up to 12 months]

    5. Establish the correlation between Artery blood gas and progression to PPF [Up to 12 months]

      Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)

    6. Establish the correlation between Pulmonary function and progression to PPF [Up to 12 months]

      Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)

    7. Establish the correlation between 6 min walk test distance (meters) and progression to PPF [Up to 12 months]

    8. Establish the correlation between Biomarkers and progression to PPF [Up to 12 months]

      Biomarkers:CCL18(pg/mL),KL-6(pg/mL),CA125(pg/mL),MMP-7(pg/mL),SP-D(pg/mL) and IL-6(pg/mL)

    Secondary Outcome Measures

    1. Prevalence of PPF [Up to 36 months]

      Prevalence of PPF in patients with fibrosing ILD.

    Other Outcome Measures

    1. Establish the correlation between Age (years) and mortality of PPF [Up to 36 months]

    2. Establish the correlation between Gender (the proportion of female and the proportion of male) and mortality of PPF [Up to 36 months]

    3. Establish the correlation between Body mass index (BMI, kg/m2) and mortality of PPF [Up to 36 months]

    4. Establish the correlation between ILD-Gender-Age-Physiology score (0-3,4-5 and 6-8) and mortality of PPF [Up to 36 months]

    5. Establish the correlation between Artery blood gas and mortality of PPF [Up to 36 months]

      Artery blood gas: PaCO2 (mmHg) and PaO2 (mmHg)

    6. Establish the correlation between Pulmonary function and mortality of PPF [Up to 36 months]

      Pulmonary function: forced vital capacity (FVC, L) and diffusion capacity for carbon monoxide of the lung (DLCO, mmol/min/kPa)

    7. Establish the correlation between 6 min walk test distance (meters) and mortality of PPF [Up to 36 months]

    8. Establish the correlation between Biomarkers and mortality of PPF [Up to 36 months]

      Biomarkers:CCL18(pg/mL),KL-6(pg/mL),CA125(pg/mL),MMP-7(pg/mL),SP-D(pg/mL) and IL-6(pg/mL)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18-80 years old

    • Agree and sign the informed consent form

    • Interstitial lung disease patients with imaging features of pulmonary fibrosis

    Exclusion Criteria:

    • Patients with idiopathic pulmonary fibrosis (IPF)

    • Pregnant or lactating women

    • mental illness or cognitive impairment

    • participating in other clinical studies

    • Unable to sign informed consent form

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Qianfoshan Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhi Guo, Principal Investigator, Qianfoshan Hospital
    ClinicalTrials.gov Identifier:
    NCT05895409
    Other Study ID Numbers:
    • YXLL-KY-2023(029)
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zhi Guo, Principal Investigator, Qianfoshan Hospital
    progressive pulmonary fibrosis
    Additional relevant MeSH terms:
    Lung Diseases
    Pulmonary Fibrosis
    Lung Diseases, Interstitial
    Fibrosis

    Study Results

    No Results Posted as of Jun 8, 2023